BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALGO 2EC

    MDR report key: 757767 · Received August 23, 2006

    Report

    Report Number
    2938854-2006-00001
    Event Type
    Other
    Date Received
    August 23, 2006
    Date of Event
    July 25, 2006
    Report Date
    August 4, 2006
    Manufacturer
    NATUS MEDICAL, INC.
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS WILL IMPLEMENT INSPECTION ON DEVICES WHEN PACKAGING TO ASSURE THAT THE LAPTOP IS SECURELY FASTENED TO THE DOCKING STATION.

    Description of Event or Problem · 1

    THE EMPLOYEE WAS UNPACKAGING THE DEVICE FROM THE BOX BY HOLDING THE FOAM SIDING. WHILE REMOVING THE DEVICE THE LAPTOP SLID AND THE EMPLOYEE TRIED TO PREVENT THE LAPTOP FROM FALLING TO THE FLOOR BY HOLDING THE DEVICE BY THE BOTTOM OF THE DOCKING STATION AND THE EMPLOYEE MANEUVERED HER FINGERS TO BETTER GRIP THE DOCKING STATION. IN THIS PROCESS, HER INDEX FINGER CAUGHT BETWEEN THE CONSOL AND DOCKING STATION AND HER FINGERNAIL SPLIT DOWN THE MIDDLE. IT APPEARED THAT THE DEVICE WAS NOT ATTACHED TO THE DOCKING STATION. THE EMPLOYEE STATED THAT THE DUAL-LOCK WAS NOT FASTENED CORRECTLY TO THE DEVICE AND IT WOULD HAVE CRACHED TO THE GROUND IF SHE HAD NOT CAUGHT IT. THE EMPLOYEE STATED ON 8/17/05 THAT HER FINGER IS "FINE" AND THAT SHE DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALGO 2EC HEARING SCREENER EWO NATUS MEDICAL, INC. ALGO 2EC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other